Artificial heart valve, implantation instrument and method therefor

Abstract

An artificial valve for repairing a damaged heart valve having a plurality of cusps separating upstream and downstream regions. The artificial valve includes a flexibly resilient frame with a plurality of peripheral anchors for anchoring the frame in position between the regions. The frame includes a central portion located between the anchors. The valve includes a flexible valve element attached to the central portion of the frame having an upstream side and a downstream side opposite the upstream side. The valve element moves to an open position when fluid pressure in the upstream region is greater than fluid pressure in the downstream region to permit downstream flow. The valve element moves to a closed position when fluid pressure in the downstream region is greater than fluid pressure in the upstream region to prevent flow reversal. The valve may be used in beating heart procedures, avoiding cardiopulmonary bypass and cardioplegia.

What is claimed is:  
     
       1. An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising: 
       a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream region and the downstream region and a central portion located along a centerline extending between the plurality of peripheral anchors and between the upstream region and the downstream region when said frame is inserted in the position between the upstream region and the downstream region;  
       a flexible valve element attached to the central portion of the frame having an upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region; and  
       an opening extending through at least one of said frame and said flexible valve element for receiving an implement.  
     
     
       2. An artificial valve as set forth in  claim 1  wherein said opening extends through the central portion of the frame and the flexible valve element. 
     
     
       3. An artificial valve as set forth in  claim 2  further comprising a releasable fastener mounted on the frame for selectively connecting the valve to an instrument. 
     
     
       4. An artificial valve as set forth in  claim 3  wherein the fastener comprises a hollow post mounted on the central portion of the frame coaxial with the opening. 
     
     
       5. An artificial valve as set forth in  claim 4  wherein said fastener comprises a threaded fastener. 
     
     
       6. An artificial valve as set forth in  claim 5  wherein said post is externally threaded. 
     
     
       7. An artificial valve as set forth in  claim 4  wherein said fastener comprises a bayonet fastener. 
     
     
       8. An artificial valve as set forth in  claim 1  wherein said flexibly resilient frame includes frame elements extending outward from the central portion, said frame elements being biased outward to engage the heart tissue and hold the frame in an expanded configuration in the position between the upstream region and the downstream region. 
     
     
       9. An artificial valve as set forth in  claim 8  further comprising a band extending around the frame elements to limit outward movement of the frame elements to the expanded configuration and to sealingly engage adjacent heart tissue. 
     
     
       10. An artificial valve as set forth in  claim 9  wherein said band includes an inner portion formed to limit outward movement of the frame elements, and an outer portion at least partially surrounding said inner portion and being biased inward, such that when the frame elements are forced inward to a collapsed configuration, the outer portion urges the inner portion inward to a position inside the frame elements. 
     
     
       11. An artificial valve as set forth in  claim 10  wherein the frame elements are biased outward by a spring force sufficient to overcome the inward bias of the outer portion, so that the outward spring force maintains the frame in the expanded configuration. 
     
     
       12. An artificial valve as set forth in  claim 11  wherein said outer portion comprises a braided mesh. 
     
     
       13. An artificial valve as set forth in  claim 12  wherein said braided mesh comprises a woven fabric of filaments, each having a width of between about 0.05 mm and about 0.13 mm. 
     
     
       14. An artificial valve as set forth in  claim 12  wherein said braided mesh comprises a material selected from the group consisting of Nitinol superelastic alloy, stainless steel alloy, Elgiloy® alloy, fiberglass, PTFE, polyester and Lycra®. 
     
     
       15. An artificial valve as set forth in  claim 10  wherein said inner portion comprises a material selected from the group consisting of PTFE, Dacron® velour, Dacron® porous cloth, a synthetic polymer and biological source tissue. 
     
     
       16. A artificial valve as set forth in  claim 8  further comprising a thin strand extending around the frame elements to limit outward movement of the frame elements to the expanded configuration. 
     
     
       17. An endothoracoscopic method of inserting an artificial valve as set forth in  claim 1  between a plurality of cusps of a damaged heart valve, said method comprising the steps of: 
       making an opening in a chest wall of a patient;  
       making an incision in a heart of the patient;  
       inserting an end of an elongate instrument through the opening made in the chest wall and the incision made in the heart;  
       positioning the inserted end of the instrument adjacent the plurality of cusps of the damaged heart valve;  
       ejecting an artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into a position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart;  
       retrieving the artificial valve into the end of the instrument;  
       repositioning the inserted end of the instrument adjacent the plurality of cusps of the damaged heart valve; and  
       ejecting the repositioned artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart.  
     
     
       18. A transluminal method of inserting an artificial valve as set forth in  claim 1  between a plurality of cusps of a damaged heart valve, said method comprising the steps of: 
       making an incision in a vessel leading to the heart;  
       inserting an end of an elongate flexible instrument through the incision made in the vessel;  
       pushing the end of the instrument through the vessel;  
       positioning the end adjacent the plurality of cusps of the damaged heart valve;  
       ejecting an artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into a position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart;  
       retrieving the artificial valve into the end of the instrument;  
       repositioning the inserted end of the instrument adjacent the plurality of cusps of the damaged heart valve; and  
       ejecting the repositioned artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart.  
     
     
       19. A transluminal method as set forth in  claim 18  further comprising performing a septostomy between the atria of the heart and pushing the instrument through an atrial septal perforation created by the septostomy. 
     
     
       20. A transluminal method of inserting an artificial valve as set forth in  claim 1  between a plurality of cusps of a damaged heart valve, said method comprising the steps of: 
       making an incision in a vessel leading to the heart;  
       inserting an end of a guide through the incision made in the vessel;  
       pushing the guide through the vessel;  
       threading an elongate flexible instrument having a hollow interior onto the guide;  
       inserting an end of the elongate flexible instrument through the incision made in the vessel;  
       pushing the end of the instrument through the vessel along the guide until the end is adjacent the plurality of cusps of the damaged heart valve; and  
       ejecting an artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into a position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart.  
     
     
       21. A transluminal method as set forth in  claim 20  further comprising performing a septostomy between the atria of the heart and pushing the instrument through an atrial septal perforation created by the septostomy. 
     
     
       22. An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising: 
       a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream region and the downstream region;  
       a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to at least a portion of the frame, said element having a convex upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a concave downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region; and  
       an opening extending through at least one of said frame and the flexible valve element.  
     
     
       23. An artificial valve as set forth in  claim 22  further comprising a releasable fastener mounted on the frame for selectively connecting the valve to an instrument. 
     
     
       24. An artificial valve as set forth in  claim 23  wherein the fastener comprises a hollow post mounted on the frame coaxial with the opening. 
     
     
       25. An artificial valve as set forth in  claim 24  wherein said fastener comprises a threaded fastener. 
     
     
       26. An artificial valve as set forth in  claim 25  wherein said post is externally threaded. 
     
     
       27. An artificial valve as set forth in  claim 24  wherein said fastener comprises a bayonet fastener. 
     
     
       28. An artificial valve as set forth in  claim 27  wherein said flexibly resilient frame includes frame elements extending outward from the central portion, said frame elements being biased outward to engage the heart tissue and hold the frame in an expanded configuration in the position between the upstream region and the downstream region. 
     
     
       29. An artificial valve as set forth in  claim 28  further comprising a band extending around the frame elements to limit outward movement of the frame elements to the expanded configuration and to sealingly engage adjacent heart tissue and form a seal with the heart. 
     
     
       30. An artificial valve as set forth in  claim 29  wherein said band includes a inner portion formed to limit outward movement of the frame elements, and an outer portion at least partially surrounding said inner portion and being biased inward, such that when the frame elements are forced inward to a collapsed configuration, the outer portion urges the inner portion inward to a position inside the frame elements. 
     
     
       31. In combination, an artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, and a guide for guiding the artificial valve between the upstream region and the downstream region, said combination comprising: 
       said artificial valve including  
       a flexibly resilient frame sized and shaped for insertion between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame between the upstream region and the downstream region and a central portion located along a centerline extending between the plurality of peripheral anchors,  
       a flexible valve element fixedly attached to the central portion of the frame so that at least a portion of the element is substantially immobile with respect to the central portion of the frame, said element having an upstream side fading said upstream region when the frame is anchored between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region, and  
       an opening extending through at least one of said frame and the flexible valve element; and  
       said flexible, elongate guide sized for receipt within the opening to guide the valve into position.  
     
     
       32. A combination as set forth in  claim 31  further comprising a holder having a hollow interior sized for holding the artificial valve when the frame is in the collapsed configuration. 
     
     
       33. A combination as set forth in  claim 32  further comprising an elongate manipulator attached to the holder for manipulating the holder into position between the upstream region and the downstream region. 
     
     
       34. A combination as set forth in  claim 33  further comprising an installer received within the hollow interior of the holder and releasably attachable to the artificial heart valve for maneuvering the artificial heart valve from the hollow interior of the holder into position between the upstream region and the downstream region. 
     
     
       35. A combination as set forth in  claim 32  wherein the holder comprises an outwardly flared end for receiving the artificial valve within the holder. 
     
     
       36. A combination as set forth in  claim 32  wherein the holder comprises internal, longitudinal grooving for guiding the flexibly resilient frame. 
     
     
       37. A combination as set forth in  claim 31  further comprising a vascular catheter. 
     
     
       38. In combination, an artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, and an instrument for inserting the artificial valve between the upstream region and the downstream region, said combination comprising: 
       said artificial valve including  
       a flexibly resilient frame sized and shaped for insertion between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame between the upstream region and the downstream region and a central portion located between the plurality of peripheral anchors, and  
       a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to the central portion of the frame, said element having an upstream side facing said upstream region when the frame is anchored between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region, and  
       an opening extending through at least one of said frame and the flexible valve element; and  
       an instrument including  
       a holder having a hollow interior sized for holding the artificial valve when the frame is in a collapsed configuration,  
       an elongate manipulator attached to the holder for manipulating the holder into position between the upstream region and the downstream region, and  
       an installer received within the hollow interior of the holder and releasably attachable to the frame of the artificial heart valve for maneuvering the artificial heart valve from the hollow interior of the holder into position between the upstream region and the downstream region.  
     
     
       39. A combination as set forth in  claim 38  wherein the frame includes a mount for selectively connecting the valve to the instrument. 
     
     
       40. A combination as set forth in  claim 39  wherein the mount comprises a post mounted on the frame. 
     
     
       41. A combination as set forth in  claim 40  wherein said post comprises a threaded fastener. 
     
     
       42. A combination as set forth in  claim 41  wherein said post is externally threaded. 
     
     
       43. A combination as set forth in  claim 42  wherein said installer includes an internally threaded portion for threadably receiving said externally threaded post. 
     
     
       44. A combination as set forth in  claim 40  wherein said post comprises a bayonet fastener. 
     
     
       45. A combination as set forth in  claim 38  wherein said holder has an outwardly flared end for receiving the peripheral anchors when the artificial valve is within the holder. 
     
     
       46. A combination as set forth in  claim 38  wherein the holder comprises internal, longitudinal grooving for guiding the flexibly resilient frame.